ALOE UP LIGHT TANNING OIL

Product NDC: 61477-226
11-digit product format: 614770226
Labeler code: 61477
Product ID: 61477-226_dc94971d-133e-9018-e053-2a95a90ad2b2
Type: HUMAN OTC DRUG
Nonproprietary name: AVOBENZONE, OCTYL SALICYLATE, HOMOSALATE, OCTOCRYLENE
Dosage form: SPRAY
Route: TOPICAL
Labeler: Aloe Care International, LLC
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2019-05-17
Marketing end: 0000-00-00
Substance: AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength: 1 g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	61477-226		I	Inactivated by FDA		2026-10-05
excluded package	package	61477-226	61477-226-24	I	Inactivated by FDA		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	61477-226-24	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	61477-226-24	`bd6a592717d7…`	`303034d00443…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2024-02-14	ALOE UP - LIGHT TANNING OIL SPF-6 (61477-226)
2024-01-30	ALOE UP - LIGHT TANNING OIL SPF-6 (61477-226)
2022-04-16	ALOE UP - LIGHT TANNING OIL SPF-6 (61477-226)
2022-01-28	ALOE UP - LIGHT TANNING OIL SPF-6 (61477-226)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61477-226-24	ALOE UP LIGHT TANNING OILSPF-6	120 mL in 1 BOTTLE, SPRAY	SPRAY	120		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61477-226	ALOE UP LIGHT TANNING OIL SPF-6 (AVOBENZONE, OCTYL SALICYLATE, HOMOSALATE, OCTOCRYLENE) SPRAY [ALOE CARE INTERNATIONAL, LLC]	5	Legacy NDC, 1 package rows	20240214_c65cb736-a82f-4df5-ae53-1a40092c41f5.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE
V06SV4M95S	HOMOSALATE	118-56-9	HOMOSALATE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
5A68WGF6WM	OCTOCRYLENE	6197-30-4	OCTOCRYLENE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61477-226-24	61477022624	120 mL in 1 BOTTLE, SPRAY (61477-226-24)	120 ml	2019-05-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ALOE UP - LIGHT TANNING OIL SPF-6 (61477-226)	Aloe Care International, LLC	2024-02-13	HUMAN OTC DRUG LABEL	5